Partnership Improves Patient Access to Apealea Outside US

Partnership Improves Patient Access to Apealea Outside US

Elevar Therapeutics and Tanner Pharma Group have partnered to make Apealea (paclitaxel micellar) accessible in areas outside the U.S. where the medication is not available.

The companies have created a global named patient program, also known as an early or expanded access program, which provides physicians with a framework to legally and ethically prescribe investigational or approved drugs for patients before they become commercially available. Under the agreement, Tanner will be the exclusive supplier of Apealea in these areas.

“We are excited to partner with Tanner to ensure patients outside of the U.S. who have no therapeutic alternatives are able to access to Apealea through a named patient program,” Alex Kim, Elevar’s CEO, said in a press release.

Apealea is an injectable and water-soluble form of paclitaxel, a known chemotherapy used in various solid tumors, including ovarian cancer. Medicines like paclitaxel that enter the bloodstream need to dissolve in water to reach therapeutic concentrations without having to be injected at very high doses.

Paclitaxel is not highly soluble on its own, and current formulations need to be coupled with substances that increase its solubility to reach cancer cells and exert its effects. But these substances can cause hypersensitivity reactions that are potentially life-threatening.

Apealea, originally developed by Oasmia Pharmaceutical and licensed to Elevar in March, overcomes this by packaging paclitaxel in micellar nanoparticles — lipid molecules that arrange themselves into spheres and spread easily throughout the bloodstream.

This formulation has been deemed not inferior to the standard paclitaxel formulation, Taxol, in a Phase 3 trial (NCT00989131) involving women with ovarian, fallopian tube, or peritoneal cancer.

This led the European regulatory authorities to approve Apealea, in combination with carboplatin, for the treatment of adult patients with epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer, who responded to their initial platinum-based chemotherapy but whose cancer eventually returned.

“We are pleased to give hope to patients around the world through our partnership with Elevar for Apealea,” said Banks Bourne, Tanner’s chairman and founder. “The named patient program will help ensure that patients who have no alternative therapeutic options for their disease receive access to Apealea in a manner that is reliable, responsible, ethical and in accordance with all local regulatory requirements.”

Elevar acquired global rights to Apealea, except in the Nordics, Russia, and certain countries in Eastern Europe. It has plans to submit a new drug application to the U.S. Food and Drug Administration.

“We are delighted to see that patients and doctors in European countries outside the Nordic region, where Oasmia has already launched Apealea, will now get early access,” said Francois Martelet, MD, Oasmia’s CEO.

“Elevar partnering with Tanner Pharma for a named patient program is a valid means to achieve that access outside of the U.S.,” he added. “We continue to support Elevar in the identification and selection of regional commercialization partners worldwide and will update our progress in due course.”